Inquiry Into The Use Of Cannabis For Medical Purposes

'ADCA

Alcohol and other Drugs
Council of Australia

Inquiry into the use of cannabis for medical purposes

by the

New South Wales Legislative Assembly General Purpose Standing Committee

21 February 2013

ADCA Submission to the NSW Legislative Council General Purpose Standing Committee

Inquiry into the use of cannabis for medical purposes

The Alcohol and other Drugs Council of Australia (ADCA) welcomes the opportunity to respond to
the New South Wales Legislative Council inquiry into the use of cannabis for medicinal purposes.
ADCA is the national non-government peak body representing the interests of the Australian
alcohol and other drugs (AOD) sector. It works with government, non-government organisations,
business and the community to promote evidence-based, socially just approaches aimed at
preventing or reducing the health, economic and social harm of alcohol and other drugs to
individuals and the broader Australian community.

This submission - and its recommendations - is supported by the Public Health Association of
Australia (PHAA). The PHAA is recognised as the principal non-government organisation for
public health in Australia and works to promote the health and well-being of all Australians. The
Association seeks better population health outcomes based on prevention, the social
determinants of health and equity principles.

An overview

Cannabis has been used as a medicine for thousands of years, with instances of its use over
centuries recorded in Asian, sub-continental and - more recently - European pharmacopeia.

Medicinal cannabis is said to have been very common in Australia in the nineteenth and early
twentieth century, although evidence to this end is poorly documented. Pharmacists are known to
have made a tincture of cannabis, often combined with opium, chloroform and morphine.
Cannabis cigarettes to treat asthma were popular until after World War II.

In his Southern Cross University PhD thesis Legalisation of medicinal cannabis in New South
Wales (2010) Graham Irvine observes that although 'there had been attempts by state
parliamentarians to ban or restrict the legal use of cannabis as medicine going back to the 1900s,
medicinal cannabis remained legal in New South Wales until the passage of the Police Offences
Amendment (Drugs) Act 1954 (NSW), which in turn was repealed and replaced by the Poisons
Act 1966 (NSW). This 1966 Act introduced even harsher penalties for the use of cannabis in any
form, whether for medicinal purposes or otherwise".

Notwithstanding, tincture of cannabis was listed in the Australian pharmacopeia until 1977. By
then, the global "war on drugs" was in full swing and cannabis was high on the hit list of police
and drug control agencies, despite being nothing more than a blip on the radar of the burden of
illness.

With the war on drugs now increasingly called into question, attitudes to cannabis use - both
recreational and medicinal - are more liberal. Most recently, 69 per cent of respondents to the
Commonwealth Department of Health and Ageing's 2010 National Drug Strategy Household
Survey supported changing legislation to permit the use of cannabis for medical purposes, while
74 per cent supported a clinical trial for people to use the drug to treat medical conditions.

New South Wales has considered the legalisation of cannabis on compassionate grounds on
several occasions. In 1999, the then Premier Bob Carr announced that the Government would
investigate the use of cannabis for medicinal purposes, with a working party to examine the
feasibility of making it available for therapeutic purposes.

The working party recommended in August 2000 that NSW introduce a compassionate regime to
assist those suffering from the range of illnesses identified in their report to gain the benefits
associated with the use of cannabis without facing criminal sanctions, pending the development
of safer and more efficient methods to deliver cannabinoids.

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ADCA Submission to the NSW Legislative Council General Purpose Standing Committee

Inquiry into the use of cannabis for medical purposes

In 2003, the New South Wales Government said it would introduce legislation to allow a four-year
trial of the medical use of cannabis, with Premier Carr saying the case for the decriminalisation of
cannabis was stronger than ever, but only for people who could not be assisted by conventional
treatment. It was proposed that people suffering from cancer, HIV, spinal injuries and other
conditions would be eligible for registration with a new Office of Medical Cannabis.

Unfortunately, the proposal failed to generate sufficient impetus and to all intents and purposes,
vanished, which raises the question whether federal and state governments have the political will
to entertain trials of medicinal cannabis.

As signatories to the 1988 United Nations Treaty, Australia is required to make it a criminal
offence to cultivate, supply or possess cannabis. The exception is for 'scientific or medical
purposes' under the earlier 1961 treaty.

Global use of medicinal cannabis

The cannabis plant has been used for medicinal purposes for thousands of years. However,
cannabis use began to decline in the early 20 th century as advances were made in modern
medicine. Nearly a century later, investigation of the therapeutic potential of cannabis is re-
emerging, perhaps because of increasing botanical drug development and the discovery of the
human endocannabinoid system.

Cannabis was first listed in the official United States pharmacopeia in 1 850, where it remained
until 1941; in the United Kingdom it was listed until 1954. The structure of the main active
ingredient of cannabis plants - delta-9 tetrahydrocannabinol (THC) - was discovered in the 60s.
More than 20 years later, researchers found the first cannabinoid receptor, followed by the
discovery that humans create cannabinoid-like chemicals within their own bodies, known as
endocannabinoids".

Plant based cannabis medicines have been officially approved for use in more than a dozen
countries including the UK, Denmark, the Czech Republic, Austria, Sweden, Germany, Spain,
Canada, Italy, Israel and New Zealand. Medicinal cannabis is available in the USA in eighteen
states and Washington DC (covering more than 40% of the national population).

In the Netherlands, medical cannabis has been available on prescription since 2003. The
cannabis is grown under strictly controlled conditions to ensure quality standards. Netherlands
health authorities have produced short information packages on its use 1 " lv . The Dutch
Government recommends that medicinal cannabis is prepared as a tea or inhaled through a
vaporiser to avoid exposure to smoke. Its literature points out that the cannabis sold in coffee
shops hardly ever meets the quality standards of medicinal cannabis, which is cultivated under
controlled conditions by licensed growers.

Like Holland, Canada has a licensed producer of medical cannabis v .

The UK has approved the use of the cannabinoid nabiximols, marketed as Sativex, in the
treatment of MS spasticity, with the recommendation that individual users discuss its suitability
with their physician". The manufacturer GW is also trialling it for the relief of cancer pain.

Specific arrangements for use or supply differ in the US where state medical marijuana laws
allow physicians to recommend cannabis and in some instances permit patients to cultivate
cannabis plants. Referenda were conducted in several American states as early as 1 996 to
legalise medical cannabis - largely with positive results. In a 201 1 study of over 1 ,700 patients
receiving medicinal cannabis in California, physicians most commonly recommended its use for
pain, insomnia and anxiety v ".

Despite this, the US Federal Administration continues to treat cannabis as a prohibited
substance, and has warned state legislatures that by approving cannabis use they are breaking

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ADCA Submission to the NSW Legislative Council General Purpose Standing Committee

Inquiry into the use of cannabis for medical purposes

federal laws. The US Justice Department has written to several states highlighting this anomaly"".
Worth noting is the letter from the Colorado Attorney General John Suthers to the state governor
John Hickenlooper which notes "explosive growth" in the number of people claiming to use
cannabis for medical purposes - approximately 123,000 registered users - since the state
enacted a medical cannabis regulatory scheme in 2000. Suthers says that the US Justice
Department will vigorously enforce federal laws relating to marijuana - even if it is permitted
under state law. The issue emerged again last November when the state voted to legalise
cannabis for recreational, non-medical use lx .

The American Medical Association's Council of Scientific Affairs recently amended its stance,
urging a change to federal laws to allow unfettered research into the use of medicinal cannabis 1 *.

Evidence that supports the use of medical marijuana

Doctors were prescribing cannabinoids even before they knew exactly how they worked.
Researchers discovered two receptors in the human body on which cannabinoids act. They are
called cannabinoid receptor 1 (CB1) and cannabinoid receptor 2 (CB2). CB1 is a receptor present
mainly in our central nervous system that plays a role in nausea, vomiting, and anxiety; it is
affected by cannabis and THC. CB2 is found in other body tissues and plays a role in our immune
system.

Cannabinoids are believed to be anti-inflammatory, mainly through activation of the CB2 receptor
and have been used mainly to alleviate symptoms of multiple sclerosis. There is also
experimental evidence to suggest that they may be immunomodulatory, that is, they may alter the
immune response by augmenting or reducing the ability of the immune system to produce
antibodies or sensitized cells that recognize and react with the antigen that initiated their
production. Some immunomodulators are naturally present in the body, and some are available in
pharmacologic preparations.

In the quest for a better evidence base on which to evaluate the positives and negatives of
cannabinoids, several major reviews have been published.

Canadian researcher Mohamed Ben Amar reviewed 72 controlled studies carried out between
1 975 and 2005, evaluating the therapeutic effects of cannabinoids, detailing where the project
was held, the number of patients assessed, the type of study and comparisons done, the
products and the dosages used, their efficacy and their adverse effects. Amar observed that
cannabinoids present therapeutic potential as antiemetics, appetite stimulants in debilitating
diseases like cancer and AIDS, analgesics, and in the treatment of multiple sclerosis, spinal cord
injuries, Tourette's syndrome, epilepsy and glaucoma xl .

A subsequent review by researchers from Leiden University in the Netherlands trod similar
ground for the period 2005-09 xii .

These reviews demonstrate that the evidence base for the use of medicinal cannabis for certain
specified conditions is strong. However, the therapeutic use of cannabis and cannabis-based
medicines raises safety concerns for patients, clinicians, policy-makers, insurers, researchers
and regulators. Although the efficacy of cannabinoids is increasingly demonstrated in randomised
controlled trials, most safety information comes from studies of recreational use.

As such Australia, where the prevalence of recreational cannabis use is among the highest in the
world xl ", may be an ideal proving ground. Despite high levels of use, recreational cannabis
accounts for only 0.2 per cent of the burden of illness in Australia - well below that of other
drugs xlv ; all illicit drugs exceed marijuana by a factor of ten, alcohol is 1 1 times greater and
tobacco 39 times. In long term studies of large populations, the effect of cannabis on life
expectancy is minimal in males and unable to be measured in females.

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ADCA Submission to the NSW Legislative Council General Purpose Standing Committee

Inquiry into the use of cannabis for medical purposes

Concerns over the severe mental health effects of cannabis apply to a small minority using
prodigious quantities of cannabis, usually on a daily basis'™.

Evidence against

Harm from cannabis used in its most common form - as cigarettes - would appear to lie in the
way it is ingested. Cannabis smokers usually inhale deeply and hold the intake to generate the
maximum effect before exhaling. As such, smoking cannabis is regarded as medically
unacceptable. The British Lung Foundation commissioned research into its health effects in
2002,™ warning strongly against cannabis smoking on the basis of the damage it caused to
lungs. Since then, the foundation has continued to publish related research findings.

As mentioned previously, The Dutch Government recommends the preparation of medicinal
cannabis either in a tea or inhaled through a vaporiser to avoid exposure to smoke.

In 2008, researchers at Montreal University reviewed safety studies of medical cannabinoids
published over the past 40 years to create an evidence base for cannabis-related adverse events
and to facilitate future cannabis research initiatives. They found that short-term use of existing
medical cannabinoids appeared to increase the risk of non-serious adverse events, while the
risks associated with long-term use were poorly characterised in the material they studied. The
research team observed that high-quality trials of long-term exposure would be needed to further
characterise safety issues related to the use of medical cannabinoids™ 1 .

In August 2000, the NSW Working Party on the Use of Cannabis for Medical Purposeshighlighted
the adverse effects of cannabis on motor skills and the mental health of vulnerable individuals.
The report said "these health risks should not rule out the use of cannabis for medical reasons,
but they must be taken seriously, particularly if long-term cannabis use is being considered for
the treatment of a chronic condition"™".

Some submissions to the working party noted that smoking cannabis posed health risks, while
others surmised that smoking allowed better dose titration than, for example, eating. Many
submissions recommended the development of alternative products or ways of taking cannabis
for medical purposes.

The Mental Health Council of Australia 2006 report Where There's Smoke, explored the
relationship between cannabis and mental health. The report revealed that the average age for
first time users in the 12-19 year cohort stood at 14.9 years. The MHCA's mental health working
group expressed particular concern because of the physiological changes that occur in brain
development at that stage of life xlx . ADCA notes that this is not the target group at the centre of
this inquiry, and that this age group with short life expectancy should not be denied the right to
use cannabis.

Safer ways to use cannabis - quality assurance

Modern horticultural techniques ensure that cannabis plants cultivated for medicine can be grown
and harvested in controlled, contaminant free conditions to produce consistently high quality
pharmaceutical products (sometimes called 'phytopharmaceuticals' or botanical drug
substances).

There is a thriving government authorised industry of licensed cannabis growers in several
countries including, as mentioned previously, Canada and the Netherlands.

Doctors and medical societies in countries like Israel and Canada can now prescribe medical
cannabis (including low THC formulations for children).

Extensive literature exploring cannabis use in treatment is available to the medical profession"".

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ADCA Submission to the NSW Legislative Council General Purpose Standing Committee

Inquiry into the use of cannabis for medical purposes

Synthetic cannabis

While not strictly within the terms of reference of this inquiry, the growth in the availability of
"synthetic" cannabis warrants mention.

While the term suggests a product manufactured possibly under controlled conditions, nothing
could be further from the truth. Synthetic cannabis consists of a range of manufactured
cannabinoids typically sprayed onto herbal products, many of which are listed as inactive on the
product packaging.

Synthetic cannabinoids are designed to affect the body in a manner similar to cannabis without
being derived from the cannabis plant. Because they can be purchased with no age restrictions,
their popularity among young people has grown. They are known by a variety of names, such as
"Kronic", "Spice" or "K2," and sometimes are referred to as "synthetic marijuana" or "fake
marijuana" because they are marketed with claims that their effects mimic those of cannabis. A
comprehensive national ban was imposed on these products in the USA last year but distributors
continued to market them as "legal" and "not for human consumption", allowing their purchase
online and in legal retail outlets.

They have been associated with agitation, anxiety, nausea, vomiting, tachycardia, elevated blood
pressure, tremor, seizures, hallucinations, paranoid behaviour, and non-responsiveness.
Because they contain different ingredients, it is difficult to identify which synthetic cannabinoids
cause which physical effects.

The US Substance Abuse and Mental Health Services Administration (SAMHSA) Drug Abuse
Warning Network (DAWN) estimates that of 120 million visits to emergency departments in 2009
at least 4.5 million were drug related. DAWN attributed nearly 1 1 ,500 presentations to hospital
emergency in 2010 to synthetic cannabinoids - three quarters of them people aged between 12
and 29, and 78 per cent of them male'" 1 .

Synthetic cannabis products have been available - often under different names - in Australia for
some time. The Department of Health and Ageing last year amended the Poisons Standard to
proscribe a number of synthetic substances.™ 1 Like the US, Australia faces the difficulty of
policing online sites like Silk Road, through which people can order drugs. Proscription of such
products is fraught with difficulties due to their uncertain composition and the ability of
manufacturers to sidestep proscription by altering the proportion of and substituting ingredients.

The National Cannabis Prevention and Information Centre's Bulletin from March 2012
summarised the legal position in each state and territory relating to synthetic cannabis™".

Considerations and recommendations

Given that Australia is a signatory to the 1 961 United Nations Treaty that specifically permits the
use of cannabis for scientific or medical purposes, ADCA supports the concept of a medicinal
cannabis regime with appropriate government controls over quality and supply. To avoid a
situation similar to that in the USA, the Australian Government would have to unambiguously
support the states and territories should they choose to trial medicinal cannabis.

Acknowledging the lack of detailed knowledge about this issue in many jurisdictions, information
for the community is very important. Incremental changes should be made from trialling through
to appraisal and approval of medicines, and each step evaluated to determine benefit and
minimal adverse consequences - and to promote the findings. Positive results should prompt
consideration of further liberalisation. Experts should be invited to recommend which conditions
warrant the highest priority for the use of medicinal cannabis, with the situation reviewed and
recommendations made to government at least annually.

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ADCA Submission to the NSW Legislative Council General Purpose Standing Committee

Inquiry into the use of cannabis for medical purposes

ADCA supports ongoing research into medicinal cannabis to determine efficacy and safety as
they relate to a range of conditions/ illnesses. It also supports the use of medicinal cannabis in
the existing legal framework - particularly in palliative cases for patients with poor life
expectancy.

ADCA recommends:

• that in the current climate, medicinal cannabis be treated as a second or third line drug for
people with intolerably severe symptoms and where more conventional medicines have
either proven ineffective or result in unacceptable side effects.

• that given the associated risks, smoking cannabis as a medical treatment, as opposed to
other forms of ingestion, should be entertained only where patients have a short life
expectancy.

• that use of medicinal cannabis be consistent with best medical practice of using the
lowest dose over the shortest duration to achieve desired results

• ongoing research to optimise dose and route of administration, quantify therapeutic and
adverse effects, and examine interactions and,

• acknowledgment that efficacy may be greater for the whole plant than for extracts, which
has significant implications for regulation of cannabis as a medicine.

ADCA thanks the NSW Legislative Assembly Social Policy Committee for the opportunity to
provide comment to the inquiry. Should you wish to discuss any issues we raise in this
submission please contact Mr Rob Gill in our office in the first instance (02 62159817, or
rob.gill@adca.org.au).

I welcome the opportunity to discuss this submission further.
Yours sincerely

David Templeman
Chief Executive Officer

21 February 201 3

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ADCA Submission to the NSW Legislative Council General Purpose Standing Committee

Inquiry into the use of cannabis for medical purposes

1 http://epubs. scu.edu. au/cgi/viewcontent.cgi?article=1191&context=theses)

" http://scienceblog.cancerresearchuk.org/2012/07/25/cannabis-cannabinoids-and-cancer-the-evidence-so-far/

111 http://www.youtube.com/watch?v=hE60H2pl_k&feature=youtu.be

iv http://www.cannabisbureau.nl/en/doc/pdf/5089-A5-BMC-Pat-ENG-web_25097.pdf

" http://www.prairieplant.com/cannimed-medicinal-marijuana.html

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x http://www.ama-assn.org/amal/pub/upload/mm/443/csaph-report3-i09.pdf

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x " Hazekamp, A., & Grotenhermen, F. (2010). Review on clinical studies with cannabis and cannabinoids 2005-2009.
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xu Johns A Psychiatric effects of cannabis BJP February 2001 178:116-122; doi:10.1192/bjp. 178.2.116
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xul http://www.blf.org.uk/Page/Special-Reports

x ™ http://www.cmaj.ca/content/178/13/1669.full

xul " http://ndarc.med.unsw.edu.au/resource/report-working-party-use-cannabis-medical-purposes-vol-l

xlx http://mhca.org.au/index.php/component/rsfiles/download?path=Publications/Where%20There%27s%20Smoke%20Cannabi
s%20and /o20Mental%20health.pdf

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XXI SAMHSA 2012, Drug-Related Emergency Department Visits Involving Synthetic Cannabinoids, The DAWN Report, Dec 4, 2012

http://www.samhsa.gov/data/2kl2/DAWN105/SR105-synthetic-marijuana.htm
xx " http://www.tga.gov.au/pdf/scheduling/scheduling-decisions-1202-final.pdf

xxl " http://ncpic.org.au/ncpic/publications/bulletins/article/synthetic-cannabinoids-the-australian-experience

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